Conformis (Nasdaq:CFMS) announced yesterday that it received FDA 510(k) clearance for its Actera hip system.
Billerica, Massachusetts–based Conformis announced the regulatory win after the market closed on Tuesday, Sept. 13. This afternoon (Wednesday, Sept. 14), shares of CFMS are up 8.5% at 29¢ apiece.
The company designed Actera with a tri-taper femoral stem, adding to its hip portfolio. Conformis said the tri-taper design is becoming “more common” among orthopedic surgeons. Its design facilitates a minimally invasive approach similar to direct anterior, offering easier access to the femur. Consequently, this results in less injury to muscles and fewer potential interactions with nerves.
Conformis said it designed the system and supporting software to offer more personalized alternatives to cementless hip stems. It leverages the company’s advanced surgical planning and “surgery in a box” delivery model.
“We’re excited to expand Conformis’ hip portfolio with the addition of Actera, to satisfy the rise in surgeon demand for tri-taper stems,” said Mark Augusti, Conformis CEO and president. “Surgeons have demonstrated a significant and growing preference for anterior total hip arthroplasty (THA) surgeries in recent years, and the innovative tri-taper stem is designed for easier placement. Peer-reviewed studies provide an increasing body of evidence that a tri-taper stem supports improved proximal load transfer and lower likelihood of implant loosening.”
Conformis is launching Actera under a limited release in select U.S. markets. The company earmarked the limited launch for the coming months.
“The Actera hip, with its tri-tapered stem, is the natural evolution of the Conformis personalized portfolio,” said Dr. Robert T. Trousdale, a board-certified orthopedic surgeon at the Mayo Clinic in Rochester, Minnesota. “It is well-suited to whichever surgical approach is chosen by the surgeon.”